“IDMP Readiness”
Connecting Data Silos
'xEVMPD' to
IDMP
IDMP regulation aims to uniquely identify pharmaceutical products, standardize product information and aid the exchange of information between pharmaceutical companies and global regulators all with the ultimate goal of improving patient safety.
Being a specialist provider of Regulatory Data Management & Technology Services, ekaGRA simplifies data consolidation and provides efficient and seamless ISO IDMP submissions services. ekaGRA’s Regulatory Information Management Solution and strategic IDMP Consulting and Implementation Services enable companies to effectively gain IDMP compliance readiness within the required timelines.
ekaGRA advantage
- Develop an integrated and holistic IDMP strategy
- Successful transition from XEVMPD to IDMP
- Structured strategy for implementing IDMP and create IDMP baseline
- Perform IDMP readiness, gap analysis and future state recommendations
- Support for Source identification, data gap analysis and mapping for IDMP
- Robust workforce with commitment for IDMP compliance
- Proven ability to fulfil client requirements with ensured quality
- Dedicated team involving CMC, PV, Artworks etc. to identify the change management triggers and maintenance of IDMP data
Ensuring a successful transition from XEVMPD to IDMP
Holistic approach to IDMP
Beyond IDMP Compliance
At ekaGRA we understand the fine details of the new IDMP requirements, infact our team of technical and regulatory consultants is able to provide you with an in-depth analysis of your existing processes and technologies and create an accurate assessment of the changes your organization needs to make in order to ensure IDMP compliance.
ekaGRA’s IDMP transition framework includes the following phases:
- Strategic planning
- Regulatory business process consulting
- System implementation & integration
- Data analysis, acquisition and management
- Data transfer
- Transition to IDMP & IDMP maintenance
What do we do?
- Regulatory Intelligence
- Regulatory Information Management
- Reporting
- IDMP
- Publishing
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- Pharmaceuticals
- Biologics
- Medical Devices
- Nutraceuticals
- Chemicals
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